Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Carbonic Anhydrase C, Antigen, Antiserum, Control
510(k) Number K823680
Device Name COAT-A-COUNT MORPHINE KIT & COMPONENTS
Applicant
Diagnostic Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5200
Classification Product Code
DDE  
Date Received12/07/1982
Decision Date 01/05/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-